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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00549211 |
A study conducted on healthy volunteers to determine the safety, tolerability and affect on the human body by experimental drug GSK557296.
Condition | Intervention | Phase |
---|---|---|
Premature Ejaculation |
Drug: GSK557296 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Crossover Assignment, Pharmacokinetics Study |
Official Title: | A Two-Part Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Oral Doses of GSK557296 in a Randomized, Single-Blind, Placebo-Controlled, Dose-Rising Design, and to Evaluate the Effect of Food on Single Oral Doses of GSK557296 in Healthy Adult Subjects |
Estimated Enrollment: | 42 |
Study Start Date: | October 2007 |
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | OTB109039 |
Study First Received: | October 23, 2007 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00549211 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Safety, Tolerability, Healthy Subjects, Pharmacokinetics |
Sexual Dysfunctions, Psychological Mental Disorders Healthy |
Sexual Dysfunctions, Psychological Mental Disorders Sexual and Gender Disorders |